Medical Advisor, US Medical Affairs - Rheumatology

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Business Unit - Medical Affairs Clinical Research Physician (CRP) is an integral member of the medical affairs, development team for strategic planning in the support of launch and commercialization activities of molecules approved for rheumatology indications.

Specific activities include developing or contributing to the regional clinical/medical plan; the development, conduct and reporting of local clinical trials; the reporting of adverse events as mandated by corporate patient safety; review process for protocols, study reports, publications and data dissemination for products; new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization.

In addition, the CRP is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective business unit global Medical Affairs team, brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase / Clinical Pharmacology, and Translational Medicine team(s).

The Clinical Research Physician serves as a scientific resource for study teams, departments, and others as needed.

Actively address payer, patient and health care providers questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.

Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.

Contribute actively on an ongoing basis to the strategic planning for currently marketed brands.

By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team.

Support training of sales representatives, and other medical representatives.

Become familiar with market archetypes and potential influence on the medical interventions for the product.

Scientific Data Dissemination/Exchange

Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals.

Support medical information associates in preparation and review of medical letters and other medical information materials.

Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff.

Prepare or review scientific information in response to customer questions or media requests.

Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).

Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis.

Develop and maintain appropriate collaborations and relationships with relevant professional societies.

Collaborate with Clinical Research Scientists (CRSs), regional clinical operations staff, statisticians, health outcomes, research scientists and selected investigators in the development of protocols and data collection requirements.

Participate in investigator identification and selection, in conjunction with clinical teams.

Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.

Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel.

Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.

Review IIT proposals and publications, as requested Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country (ies) or global Development team.

Understand and actively address the scientific information needs of all investigators and personnel.

Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.

Regulatory Support Activities

Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label.

Provide medical expertise to regulatory scientists, support / assist in the preparation of regulatory reports participate in advisory committees.

Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS).

Scientific / Technical Expertise and continued development

Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years).

Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product.

Responsible for the scientific training of the clinical study team.

Acts as scientific consultant and protocol expert for clinical study team members and others in medical.

Explore and take advantage of opportunities for extramural scientific experiences.

Company OverviewAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.Basic QualificationsMedical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
Additional Skills/Preferences

Medical Doctor Specialty in Rheumatology or Internal Medicine preferred with established expertise in medical affairs.

Knowledge of drug development process relevant to country/region preferred

Demonstrated ability to balance scientific priorities with business priorities